Taiho Oncology

  • Senior Study Manager, Clinical Operations

    Job Locations US-NJ-Princeton
    Category
    Clinical
    Type
    Regular Full-Time
  • Position Summary

    Taiho Oncology, Inc. works urgently to discover and develop innovative cancer treatments. As cancer evolves, we evolve with it—bringing novel technology to cornerstone chemotherapies, while at the same time optimizing new targeted agents. Advanced technology, dedicated investigators, and incomparable facilities—these vast resources empower us to redefine the way the world treats cancer. It’s our work; it’s our passion; it’s our legacy. Organizes and facilitates the overall planning, coordination, tracking and general performance of clinical studies that support the Clinical Development Plan. The Senior Study Manager (SSM) is responsible for ensuring clinical study quality and consistency of performance, and in conjunction within Clinical Operations and with all other teams/departments is responsible for overall timeline adherence. A critical component of the position is the peer management, support of, and coordination with contract research organization (CRO) personnel, consultants, contractors, and other colleagues to ensure adequate resource volume and quality is maintained on the studies for which the SSM is responsible.

    Responsibilities

    • Assumes overall responsibility for the preparation monitoring and management options (either in-house or contracted to a CRO), ethics committee approval, development of recruitment strategies to increase patient enrollment, the provision of clinical trial materials and management of the trial contracts with the internal team, CROs and study sites. Participates in the preparation of protocols and Case Report Forms (CRFs), and data management plans.
    • Works with CROs to develop electronic systems, establish processes and plans, mitigation strategies, etc. in order to establish a foundation for clinical trials.
    • Identifies study specific training with the CROs Project Manager for implementation with Clinical Research Associates (CRAs) and other clinical staff.  Topics include but are not limited to team communication, computer software and IT training, protocol and CRF, adverse event reporting and the importance of pharmacovigilance.
    • Responsible for the financial management of the clinical trial in conjunction with his/her supervisor and finance department.
    • Establishes procedures to ensure adherence to trial protocols and administrative requirements.
    • May be responsible for management of Phase I, II, Ill, or IV clinical trials.
    • Efficiently maintains and manages the tracking of timeline milestones for all studies as well as overall day-to-day operations of clinical studies.
    • Ensures the timelv recruitment of trial participants with secure randomization processes (if applicable) and subsequent efficient and effective data management.
    • Monitors the trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems.
    • Works to ensure that the trial is meeting its targets, is producing meaningful output and to predict and plan any changes that warrant requests to changes in protocol, funding, or time.
    • Participates on corporate global clinical research teams ensuring that colleagues are updated on all relevant issues. 
    • Develops systems to track projects including all study, investigator and ethical review board information, patient recruitment activity, and financial management.
    • Ensures that all aspects of GCP are complied with at all times through provision of training at start-up and initiation meetings for clinical trials and on-going SOP development.
    • Acts as the point of contact for all external and internal functional teams.
    • Liaises with the Trials Steering Committee, Data Monitoring, and Ethics Committee as required.
    • Provides  regular  and  ad  hoc  information,  both written  and  verbal,  to  all the  trial participants, internal/external teams including reports, updates, guidance, preformed commitments and, possibly, a newsletter.
    • If required and when applicable, co-monitors or performs CRA activities.  These responsibilities are inclusive of but not limited to the following:
    • Acts as the main line of communication between the sponsor and the investigator.
    • Locates and assesses the suitability of facilities at a study center. Verifies that all research staff and facilities have adequate qualifications and resources and these remain adequate throughout.
    • Ensures that study centers are set up properly, which includes ensuring each center has the trial materials, investigational products, and training according to trial­ specific industry standards.
    • Responsible for the safety and proper conduct throughout the trial.
    • Verifies that the investigator follows the approved protocol and all GCP procedures.
    • Verifies that source data/documents and other trial records are accurate, complete, and maintained through review of monitoring reports or co-monitoring visits.
    • Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs. Verifies that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV).
    • Communicates deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to internal management and the investigator as applicable.
    • Works with internal and external functional teams to ensure all used and unused trial supplies are accounted for.
    • Manages the closing down of study centers on completion of the trial.
    • Provides support to a clinical team including maintenance of documentation, clinical tracking and information retrieval.
    • Prepares and manages clinical documentation and reports.
    • Serves as a central contact for communications/correspondence and associated documentation.
    • Manages and coordinates internal/external team meetings and internal/external investigator meetings.
    • Ability to interact and communicate with Taiho’s partners for both planning and operational execution of day to day activities.
    • Must possess the ability to multi-task and effectively prioritize in order to ensure clinical trial goals.
    • Has demonstrated the ability to lead cross functional teams; excellent organization, negotiation and team motivation skills are essential. Make independent choices and take responsibility for own actions
    • Has demonstrated knowledge of, and competence in, application of FDA/GCP/ICH guidelines.
    • Recognize potential obstacles and work to resolve them within set timelines
    • Prepares PowerPoint slide decks and other presentation materials for a variety of internal and external presentations.
    • Assists in the smooth office administration of the clinical team (e.g., correspondence, calendar, expense reports, telephone, mailings, etc.).
    • Participates in a variety of other projects as required.
    • Demonstrates a confident and influential approach.
    • Delivers work conscientiously and precisely even when under pressure.

    Qualifications

    Educational Requirements:   

    A 4-year degree preferably in the biological sciences. Requires a good understanding of medical terminology.

     

    Experience: 

    3-5 years clinical trial management experience in the pharmaceutical industry preferably with 5+ in clinical operations.

     

    Other Skills and Abilities:

    • Attention to details.
    • Solution oriented and exceptional collaboration skills.
    • A team player and able to work in a dynamic environment with attention to high quality results.
    • Understand the needs of others
    • Has demonstrated the use of excellent communication skills, command of medical terminology and of the application of scientific/medical and clinical concepts used to conduct Phase I-IV clinical trials.
    • Well organized.
    • Excellent communication skills both verbal and written.
    • Professional in appearance and manner.
    • Ability to multi-task effectively and efficiently on a variety of projects.
    • Good team player with positive “can do” attitude.
    • Ability to focus on projects and work with minimal supervision.
    • Good proofreading skills.
    • Takes initiative and utilizes good judgment.

    Language Skills:

    • Ability to effectively present information and respond to questions internally and externally.

     

    Mathematical Skills:

    • Ability to work with mathematic concepts such as probabilities and statistics.
    • Ability to apply concepts such as proportions, fractions, percentages, to practical situations.

    Reasoning Ability:

    • Ability to collect information, define problems, establish facts, draw conclusions and propose feasible actions.

    Computer Skills:

    • Outstanding computer skills in Word, Excel, PowerPoint, and MS Project.

    Physical Demands: 

    • While performing duties related to this job the employee is required to sit, talk, and hear.
    • The employee is occasionally required to walk.

    Work Environment: 

    • The noise level in the work environment is usually quiet.

    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

     

    The incumbent in this position may be required to perform other duties, as assigned.

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